A Senate bill reauthorizing PDUFA will likely go to a vote tomorrow, with a system of fines for false or misleading ads similar to that used by the FTC replacing the two-year moratorium on ads for new drugs proposed in the original legislation.
In addition to issuing warning letters to companies for ads deemed false and misleading, the FDA would have the option of hauling the offending firms before an administrative law judge. If found to be in violation, companies could be fined $150,000 initially and $300,000 if they ignore the sanctions and continue running the ad.
The bill, S. 1082, or the FDA Revitalization Act, would also mandate pre-submission of ads to FDA but not pre-clearance. A provision mandating language warning of as-yet unknown potential risks for new drugs, has been scotched, said Advertising Coalition sources.
Jim Davidson, executive director of the Advertising Coalition, pronounced himself satisfied with the changes. “These were three of the most insidious restrictions on speech that we’ve seen for a long time, however well-intentioned,” said Davidson. “We were seeking a middle ground.”
A spokeswoman for Sen. Kennedy (D-MA), who co-sponsored the bill and is shepherding it through, said his staff is “optimistic” that it will pass and has received assurances from the White House that the legislation in its current form would not be vetoed.
The bill hit a snag with the passage of an amendment offered by Sen. Dorgan (D-ND) authorizing reimportation of drugs, which would have ensured a presidential veto. But that measure was quickly voided by the passage of an amendment authored by Sen. Cochran (R-MS) requiring that FDA ensure the safety and efficacy of any imported drugs.
At press time, sources said Dorgan is still balking over importation and labeling concerns, but the question of DTC has been resolved to the satisfaction of Sens. Roberts (R-KS), who opposed a moratorium, and Harkin (D-IA), who favored restrictions on consumer ads, and a vote to cap debate at 30 hours has passed.